AccurKardia, an innovator in ECG-based diagnostics technology, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its ECG-based, AI-powered AK+ Guard hyperkalemia detection software. 

This investigational technology uses Lead I ECG data to alert patients and clinicians of moderate to severe episodes of hyperkalemia (excess potassium in the blood) which can lead to sudden cardiac arrest.

“The two FDA actions supporting AK+ Guard mark another major milestone in AccurKardia’s journey towards achieving our mission to improve patient outcomes and save lives by transforming ECG into a broad biomarker,” said Juan C. Jimenez, co-founder and CEO of AccurKardia. “We believe the current standard of care for hyperkalemia detection and monitoring is underserving patients, and we aim to deliver a speedier and more accessible pathway to detection and risk management that will make a meaningful impact on patient care.”

AK+ Guard is designed to work with a wide range of FDA-cleared consumer and clinical wearables that currently capture Lead I ECG data, enabling hyperkalemia monitoring outside of the clinic and earlier intervention for high-risk populations. These include those with end-stage renal disease, chronic kidney disease (CKD), and other risk factors.

The AK+ Guard designation follows AccurKardia’s recently received Breakthrough Device Designation for its Aortic Valve Stenosis (AVS) screening software, AK-AVS, which is designed to leverage the ubiquity of the electrocardiogram (ECG) to identify potential cases of aortic valve stenosis in millions of ECGs already present in healthcare system electronic health records.

Also, the AK+ Guard was recently accepted as one of only 62 devices in the FDA Total Product Life Cycle Advisory Program (TAP). The TAP program provides earlier and more frequent engagement with the FDA, helping accelerate the regulatory process, improve the quality and timeliness of device evaluations, and ultimately speed commercialization.